Any article or other information or content expressed or made available in this Section, is that of the respective author and not of the OBA.
Canada is in the midst of an opioid crisis. For more than a decade, the country has been experiencing a rapid rise in rates of opioid-related harms from both prescription opioids and increasingly potent illegal drugs. In Canada there were 2,861 apparent opioid-related deaths in 2016.[1] Ontario, following behind British Columbia, experienced the second highest amount of deaths, with 867 Ontarians dying from opioid-related causes.[2]
The problem may have begun in the early 1990s when Purdue Pharma received a patent for a new painkiller named OxyContin. According to the patent, the drug was revolutionary because it was able to “substantially improve the efficiency and quality of pain management” without unacceptable side effects, such as the highly addictive quality of all narcotics.[3] The painkiller was unique, it had a controlled-release oxycodone feature, which meant the medication would be released in the body over a 10-hour period compared to the 4-hour dosage cycle other painkillers provided. Purdue Pharma claimed that the substantial reduction in daily dosages would make it more effective and prevent patients from experiencing the addictive high provided by other painkillers.
In 1996, Health Canada gave its approval allowing Purdue Pharma to bring OxyContin to the market. Physicians were told that the pill’s slow release quality reduced the high experienced by the patient, with a lower risk of abuse and dependence compared to other pain medications currently on the market. Well-intentioned physicians were convinced that the drug was more effective at treating pain, and thus expanded their use of OxyContin.[4] The drug was used to relieve moderate to severe pain in all types of patients, and prescriptions were provided for everything from backaches to illnesses causing chronic pain.[5]
As the use of OxyContin continued, the highly addictive quality of the drug was revealed. Patients prescribed the medication became tolerant, requiring higher doses to treat their pain, thereby becoming dependent on the drug.[6] In 2012, as public awareness of the highly addictive nature of OxyContin grew, Purdue Pharma removed the drug from the market.[7] However, the introduction of opioid therapy for the management of chronic pain created a mass market for opioids by creating a new addictive product. As a result, organized crime filled the void and more potent drugs such as Morphine, Hydromorphone, Heroin, Fentanyl and Fentanyl analogues such as Carfentanil began appearing on the streets.[8] The illicit drugs are often counterfeit Oxycodone tablets mixed with other drugs, such as cocaine and other stimulants. Not knowing the composition of the tablets, drug users are at high risk of overdosing, especially from drugs such as fentanyl, in which a small dose is 10 times as potent as Oxycodone.
Initially, the Government of Canada’s reaction to the opioid epidemic did not provide an effective solution to the problem. From 2006 to 2015, Canada launched a War on Drugs with resources focused on prosecuting low-level offenders and shutting down safe injection sites for illegal drugs.[9] But the root of the problem was in the overprescribing of an addictive drug whose risks are substantial and benefits uncertain. Solving the problem would require treating the addiction. In 2016, Canada changed its approach to the new Canadian Drugs and Substances Strategy, implementing legislative and regulatory changes to address the concerns of the epidemic.[10]
Legislative and Regulatory Changes
First, in an attempt to reduce harm, the Government of Canada made legislative changes to support the establishment of supervised consumption sites (SCS) by streamlining application requirements to obtain the exemption to the Controlled Drugs and Substances Act (“CDSA”) that is needed to operate.[11] Evidence shows that, when properly established and maintained, SCS save lives and improves health by providing a place for people to use their drugs under the supervision of trained personnel, and offering linkages to other health and social services. As of November 2017, there are over 25 approved sites across the country, prior to this change, there had only been two.
Second, to make it more difficult to manufacture illegal drugs in Canada, it is now illegal to import unregistered pill presses into Canada and to possess, transport, import or sell anything intending to be used to traffic or produce any controlled substance without authorization.[12] Law enforcement can now take early action against suspected illegal drug production, including, for example, the production of counterfeit pharmaceutical tablets that contain fentanyl.
Third, changes made to the CDSA allows temporary accelerated scheduling by the Minister of Health to quickly control a new and dangerous substance that is not subject to the CDSA.[13] The substance can be quickly scheduled, pending a comprehensive review and decision on permanent scheduling.
Fourth, changes were made to the Customs Act and the Proceeds of Crime (Money laundering) and Terrorist Financing Act allowing border officials to open small mail items weighing 30 grams or less, in order to detain or seize illegal substances, such a fentanyl.[14] Now, international mail of any weight can be opened when there are reasonable grounds to suspect the item contains prohibited, controlled or regulated goods. The amendment intends to address the issue of fentanyl crossing the border into Canada by way of multiple small packages being sent through international mail.
Finally, to reduce the fear of police attending overdose events, parliament passed the Good Samaritan Drug Overdose Act, in May 2017, providing legal protection for individuals who seek emergency help during an overdose.[15] Further, Justice Canada continues to explore possible legislative proposals that could enhance judicial discretion and allow courts to impose just sentences that take into account offenders’ life circumstances.[16]
Regulatory actions taken by Health Canada include: making Naloxone available without a prescription; allowing physicians to apply to Health Canada to request access to medical grade heroin for their patients; importing of medications approved elsewhere for urgent public health needs; and further restricting access to six chemicals used to make fentanyl by scheduling them under the CDSA.[17] In 2015, Health Canada provided The National Pain Center at McMaster University funding to develop new national guidelines for safely prescribing opioids.[18] Subsequently, The 2017 Canada Guideline for Opioids for Chronic Non-Cancer pain was produced and addresses the overprescribing of these medications by physicians.
Ontario Action
Ontario has also introduced an opioid strategy “to prevent opioid addiction and overdose by enhancing data collection, modernizing prescribing and dispensing practices, and connecting patients with high-quality addiction treatment services.”[19] Public Health Ontario launched the Interactive Opioid Tool to allow users to explore the most recent opioid-related morbidity and mortality data.[20] The Ministry of Health and Long-Term Care (MOHLTC) is working on harm reduction strategies for those dependent on opioids. These include Methadone treatment clinics, needle exchange programs, and free Naloxone kits.[21] The Ministry is working on developing Overdose Prevention Sites that will offer supervised injection, harm reduction supplies, and Naloxone.
The College of Physicians and Surgeons of Ontario (“CPSO”) recognizes that prescribing behaviours of physicians must be addressed to help solve the problem. CPSO aims to “facilitate safe and appropriate opioid prescribing by physicians to patients; protect patient access to care; and reduce risk to both patients and the public.”[22] Further, to aid physicians, CPSO has updated its Prescribing Policy as of September 2017 to reflect The 2017 Canadian Guidelines for Opioids for Chronic Non-Cancer Pain.
Lawsuit Against Purdue Pharma
In April 2017, Purdue Pharma agreed to pay $20 million to settle a class-action lawsuit. The class-action represented approximately 1,500 Canadians who became addicted to the medication after being prescribed it.[23] The lawsuit accused the company of knowing but not disclosing the risk of addiction to the medication.[24] But this was not the first time Purdue Pharma entered into a settlement regarding OxyContin. In 2007, Purdue Pharma’s U.S. parent and 3 of its top executives settled criminal and civil charges against them for misbranding OxyContin as less addictive than other narcotics.[25] The company settled by paying $634.5 million in fines.
Future management of the opioid crisis will require the continued collaboration of the many organizations positioned to provide prevention, education, and enforcement to combat the high mortality rates. A key area of concern contributing to the crisis was the overprescribing of opioids by well-intentioned physicians. The 2017 Canadian Guideline for Opioids for Chronic Non-Cancer Pain has addressed these concerns and the CPSO has been ensuring Ontario physicians are educated on the matter. Continued monitoring of the crisis through data collection will provide feedback on whether the measures taken to date have been effective in reducing the problem and preventing future harm.
Any article or other information or content expressed or made available in this Section, is that of the respective author and not of the OBA.
[1] Special Advisory Committee on the Epidemic of Opioid Overdoses. National report: Apparent opioid-related deaths in Canada (January 2016 to June 2017) Web-based Report. Ottawa: Public Health Agency of Canada; 2017. https://www.canada.ca/en/public-health/services/publications/healthy-living/apparent-opioid-related-deaths-report-2016-2017-december.html
[2] Opioid-Related Morbidity and Mortality in Ontario, Public Health Ontario; 2018. https://www.publichealthontario.ca/en/dataandanalytics/pages/opioid.aspx
[3] Robertson, Grant and Howlett, Karen. “How a little-known patent sparked Canada's opioid crisis.” theglobeandmail.com. The Globe and Mail, 30 Dec. 2016. Web. 8 Apr. 2018.
<https://www.theglobeandmail.com/news/investigations/oxycontin/article33448409/>.
[4] Karen, Howlett. “Canada's Opioid Crisis.” thecanadianencyclopedia.ca. Historica, 7 Jul. 2017. Web. 8 Apr. 2018.
< http://www.thecanadianencyclopedia.ca/en/article/canadas-opioid-crisis/>.
[11] Health Canada. “Government of Canada Actions on Opioids: 2016 and 2017.” Canada.ca, Government of Canada , 30 Nov. 2017, www.canada.ca/en/health-canada/services/publications/healthy-living/actions-opioids-2016-2017.html.
[19] "Ontario Taking Action to Prevent Opioid Abuse, Province Enhancing Reporting System, Connecting Patients with High Quality Treatment." Newsroom. Ministry of Health and Long-Term Care, 12 Oct 2016. Web. 8 Mar 2018. <http://news.ontario.ca/mohltc/en/2016/10/ontario-taking-action-to-prevent-opioid-abuse.html>.
[20] Supra, note 2.; Boyko, Robert. “Opioid Crisis in Ontario.” Emerging Risks in Health Law, 9 February 2018, Ontario Bar Association, Panel Discussion.
[22] "Opioid Position Statement ." The College of Physicians and Surgeons of Ontario , Web. 8 Mar 2018. <http://www.cpso.on.ca/CPSO/media/documents/Positions%20and%20Initiatives/Opioids/Opioid-Position-Statement.pdf>.